Virtual Reality Training Program for Ambulatory Patients With Chronic Gait Deficits After Stroke

A Randomized Controlled Trial of a Virtual Reality Training Program for Ambulatory Patients With Mild-to-moderate Chronic Gait Deficits After Stroke

The purpose of this study is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).

Detailed Description

Virtual reality (VR) systems enable the learning of simple and complex skills in a controlled virtual environment; i.e., one in which the different components (constraints) of the environment can be displayed, graded, changed and monitored in a quantitative manner.

Small preliminary studies suggest that VR may be used to augment chronic stroke rehabilitation and may enhance cortical reorganization. Our aim is to examine the feasibility and efficacy of a virtual reality program for ambulatory patients with mild-to-moderate chronic gait deficits after stroke. Study design-a single center randomized controlled trial of an experimental group and a usual care group.

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan
    • Tel Hashomer, Ramat Gan, Israel, 52621
      • Sheba Medical Center, Strok Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Main Inclusion Criteria:

• Stroke within 3-72 months.
• Mild-to-moderate residual gait deficits after the index stroke with preserved capacity for ambulation without or with an assistive device (e.g., walker, cane) or orthotics (e.g. AFO).

Main exclusion Criteria:

• Unstable cardiac or other medical condition or aphasia, dementia or other significant neurological disease limiting ability to train.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A,; Virtual Reality training for an overall of 18 sessions 2/week + usual care.	Device: Virtual reality system (CAREN™ Integrated Reality System; MOTEK BV, Netherlands).; Training 2/w for 9 weeks (total 18 sessions).
No Intervention: B,; Usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Community ambulation using Step Activity Monitor (SAM)	Baseline X2, post training (week 9-10), retention (week 20-24)
Gait analysis (GaitRite system) including dual task	Baseline X2, post training (week 9-10), retention (week 20-24)
Body sway- displacement of center of pressure (CoP) as indicated by the reactive forces from platform.	Baseline X2, post training (week 9-10), retention (week 20-24)
Timed Up and Go	Baseline X2, post training (week 9-10), retention (week 20-24)

Secondary Outcome Measures

Outcome Measure	Time Frame
Functional Reach	Baseline X2, post training (week 9-10), retention (week 20-24)
Four Stick Stepping Test (FSST)	Baseline X2, post training (week 9-10), retention (week 20-24)
3DGait Analysis system	Baseline X2, post training (week 9-10), retention (week 20-24)
6 minute walk	Baseline X2, post training (week 9-10), retention (week 20-24)
Self-induced perturbations and reaction to perturbations on platform	Baseline X2, post training (week 9-10), retention (week 20-24)

Collaborators and Investigators

• Sponsor: Sheba Medical Center
• Investigators: Principal Investigator: David Tanne, MD, Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: January 14, 2008
• First Submitted That Met QC Criteria: January 24, 2008
• First Posted (Estimate): January 25, 2008

Study Record Updates

• Last Update Posted (Estimate): June 16, 2011
• Last Update Submitted That Met QC Criteria: June 15, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: stroke chronic gait deficits virtual reality training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: SHEBA-07-4780-DT-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No